Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis
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Purpose
Seasonal/perennial allergic rhinitis (SAR/PAR) is a common childhood illness. One of the leading therapies for the treatment of SAR/PAR is intranasally inhaled corticosteroids (ICS). One of the major long-term safety concerns is whether ICS interferes with normal growth in allergic rhinitis children. Recent evidence suggests that nasal ICS may cause decreased growth. However, the effect of nasal ICS on long-term growth and the attainment of final adult height is unknown. Another potential systemic adverse effect of ICS use is suppression of the hypothalamic-pituitary-adrenal axis function. The primary hypothesis of this study is that triamcinolone acetonide aqueous nasal spray (TAA) will have no effect on measured adult height in relation to target adult height in children with allergic rhinitis.
| Study Type: | Observational |
| Official Title: | Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis |
Eligibility| Ages Eligible for Study: | 6 Years to 13 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male/Female aged 6-13 years of age
- Diagnosis of SAR/PAR, with symptoms within the past 3 months
- Positive skin test to inhalant allergen with negative saline control
- No previous use of intranasal inhaled, oral, IV or topical steroid use within past 6 months.
- If the subject has asthma, only mild intermittent (per NAPP) guidelines treated with PRN bronchodilator
Exclusion Criteria:
- screening height outside the 5th and 95th percentiles
- History of abnormal growth
- Any other chronic condition beside allergic rhinitis or mild intermittent asthma
- Subject who has insufficient allergic rhinitis symptoms to require daily therapy during the trial.
- Subject with a known hypersensitivity to any active ingredients or excipents in the study medications
- Subject with nasal candidiasis, acute or chronic sinusitis, significant nasal polyposis (impairs nasal breathing), or other gross anatomical deformity of the nose sufficient to impair nasal breathing (e.g., deviated septum)
- Subjects with a history of substance abuse, mental illness or retardation
- Subjects with a history or presence of glaucoma or posterior subcapsular cataract
- Subjects with nocturnal enuresis.
- Use of Theophylline, Intal/Tilade or leukotriene modifiers.
Contacts and Locations| United States, Pennsylvania | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Principal Investigator: | David Skoner, MD | West Penn Allegheny Health System |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00189449 History of Changes |
| Other Study ID Numbers: | IST Nasacort AQ NAS.US1.631, RC - 3421 |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 30, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by West Penn Allegheny Health System:
|
Allergic Rhinitis Allergy Growth |
Additional relevant MeSH terms:
|
Hypersensitivity Rhinitis Immune System Diseases Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013